Regulatory gaps in India's medical device framework: The case of Johnson and Johnson's faulty hip implants.

Abstract

The Johnson and Johnson faulty hip implant case represents one of the most significant crises in medical device history, impacting nearly 93000 patients worldwide. In response to alarming failure rates and a global recall in August 2010, countries such as Australia, the United States, and the United Kingdom quickly implemented revision surgeries and reimbursement programs to protect patient safety. In stark contrast, India's response was alarmingly delayed; defective implants continued to be sold even after the global recall. By the time the import license was revoked, and the Central Drugs Standard Control Organization issued a recall notice, these implants had already been involved in 4700 surgeries across India. This paper explores the systemic weaknesses in India's medical device regulatory framework that contributed to this delayed action, resulting in many patients suffering from serious health complications. It highlights deficiencies in monitoring and reporting mechanisms, inadequate regulatory oversight, and insufficient approval processes. Furthermore, the inability to trace affected patients and provide necessary compensation underscores significant gaps in regulation. Although subsequent legislative reforms were introduced, this paper argues that substantial loopholes remain, posing risks for future incidents. Thus, urgent, comprehensive, and enforceable regulatory measures are needed to increase patient safety.